In a small, proof-of-concept
study, treatment with a vaccine called Bacillus Calmette-Guerin (BCG) killed
off disease-causing autoimmune cells and improved insulin sensitivity as
measured in a small group of patients, Denise Faustman, MD, PhD, of Harvard,
and colleagues reported online in PLoS One.

The findings suggest that
"BCG or other stimulators of host innate immunity may have value in the
treatment of long-term diabetes," they wrote.

TNF at high doses, however,
causes systemic toxicity, causing side effects in patients. So instead the
researchers sought an alternative approach with an FDA-approved vaccine that
can induce production of TNF by triggering the innate immune
response.

They conducted a
proof-of-concept study in patients with longstanding type 1 diabetes; mean age
was 35.

Six patients received
injections of either the BCG vaccine or a placebo and were compared with their
baseline statistics, healthy controls who did not have diabetes, and 57
reference patients with type 1 diabetes and 16 reference patients who didn't
have the disease.

Faustman and colleagues took
weekly blood samples over 20 weeks, assessing insulin-autoreactive T cells and
regulatory T cells (Tregs) — those that suppress insulin-autoreactive
T cells — as well as other antibodies.

They also measured C-peptide
levels, a marker of insulin sensitivity.

They found that all of the
patients who had the BCG vaccine had increases in dead insulin-autoreactive T
cells — as did one placebo-treated patient who developed acute
Epstein Barr Virus (EBV) infection, which is known to induce production of
TNF.

"The patient's EBV status
and receipt of placebo saline injections fortuitously enabled us to compare the
serial T cell and pancreas effects of EBV- and BCG-triggered innate immune
responses in the same study," the researchers wrote.

The vaccine appeared to
improve insulin sensitivity, with transient but significant increases in
C-peptide levels for two vaccine recipients.

From their findings, the
researchers concluded that the vaccine, at low doses, appears safe and well
tolerated, and that it likely "ameliorates the advanced autoimmune process
underlying type 1 diabetes by stimulating TNF, which selectively kills only disease-causing
cells."

Future trials should
investigate higher doses or more frequent BCG administration, they
wrote.

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